Dia Reptin
FDA 510(k) K841365 · Diatech, Inc.
510(k) numberK841365
Submission
- Device name
- Dia Reptin
- Applicant
- Diatech, Inc.
Mchenry, IL, US - Received
- April 2, 1984
- Decision date
- June 1, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIR – Reagent, Russel Viper Venom
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8950
- Specialty
- Hematology
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| K132130 | Reagent, Russel Viper Venom - la ScreenGIR · Special | Dsrv, Inc. | 01/10/2014SE |
| K132076 | Reagent, Russel Viper Venom - la ConfirmGIR · Special | Dsrv, Inc. | 01/10/2014SE |
| K110031 | Hemosil Drvvt Screen & Hemosil Drvvt ConfirmGIR · Traditional | Instrumentation Laboratory CO | 08/24/2011SE |
| K083878 | Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon laGIR · Traditional | R2 Diagnostics, Inc. | 06/25/2010SE |
| K061805 | Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmGIR · Traditional | Diagnostica Stago, Inc. | 12/06/2006SE |
| K000528 | Accuclot Drvvt Confirm, Catalog No. A62119GIR · Traditional | Sigma Diagnostics, Inc. | 04/07/2000SE |
| K000527 | Accuclot Drvvt Screen, Catalog No. A6094GIR · Traditional | Sigma Diagnostics, Inc. | 04/07/2000SE |
| K990580 | Cryocheck la Sure, Model SUR25-10GIR · Traditional | Precision Biologic | 07/28/1999SE |
| K990579 | Cryocheck la Check, Models CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)GIR · Traditional | Precision Biologic | 07/23/1999SE |
| K990302 | Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to…GIR · Traditional | Instrumentation Laboratory CO | 04/08/1999SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K881685 | Fibrinogentest-OGIS · Traditional | 08/09/1988SE |
| K854938 | Coascreener/Diascreenerblood Plasma Timing Inst.JPA · Traditional | 03/12/1986SE |
| K854090 | DIATIMER-2 Blood Plasma Clot Timing InstrumentJPA · Traditional | 01/06/1986SE |
| K854089 | DIATIMER-1 Blood Plasma Clot Timing InstrumentJPA · Traditional | 01/06/1986SE |
| K842286 | Dia T1, T2 & T3JPK · Traditional | 09/11/1984SE |
| K841523 | Owren's Veronal BufferrJPA · Traditional | 06/01/1984SE |
| K841462 | Heparin Coagulation Control Plasma 1-JPA · Traditional | 06/01/1984SE |
| K841366 | Dia FibrinKQJ · Traditional | 06/01/1984SE |
| K841461 | Coagulation Control Plasma Level 1/2/3GGP · Traditional | 05/02/1984SE |
| K840802 | Dia Thrombin Dia PlastinGJS · Traditional | 05/01/1984SE |
Questions and answers
When was Dia Reptin cleared by the FDA?
Dia Reptin (K841365) received a 510(k) decision of Substantially Equivalent on June 1, 1984, 60 days after the submission was received.
What is the product code of K841365?
The FDA product code is GIR – Reagent, Russel Viper Venom, a Class I (low risk) device regulated under 21 CFR 864.8950.